CClinicalTrials.gg
CompletedNCT02758041Updated Sep 7, 2017

A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

An interventional study of Sebacia Microparticles in Facial Acne Vulgaris, sponsored by Sebacia, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by Sebacia, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
16 Years to 45 Years
Sex
All
01

Study summary

This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

02

Conditions studied

  • Facial Acne Vulgaris

Browse trials for

Keywords

  • Acne
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 85 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Sebacia, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, 16-45 years of age.
  2. Moderate to moderately-severe facial inflammatory acne vulgaris
  3. Fitzpatrick skin phototype I-III

Exclusion criteria

Exclusion Criteria:

  1. Pregnant, lactating, nursing or planning to become pregnant
  2. Tattoo in the treatment area
  3. Active skin disease, excessive scarring or excess facial hair in the treatment area
  4. Certain current or recent acne treatments
  5. Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
  6. Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
  7. Known allergy to gold
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Sebacia Microparticles

    Device: Sebacia Microparticles

Interventions

  • DeviceSebacia Microparticles
06

What researchers measure

Primary outcomes

  1. Percent reduction in lesion count from baseline

    Time frame: Baseline, Week 12, Week 24, Week 36

Secondary outcomes

  1. Improvement in Investigator Global Acne Score

    Time frame: Baseline, Week 12, Week 24, Week 36

07

Study locations

3 sites
  • Lasercenter North
    Aalborg, 9220, Denmark
  • Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
    Copenhagen, 2400, Denmark
  • SKINPULSE Dermatology Laser & Beauty Center
    Geneva, 1205, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02758041
Lead sponsor
Sebacia, Inc.
Responsible party
Sponsor
First posted
May 2, 2016
Start date
Feb 2016
Primary completion
Jan 2017
Completion
Feb 2017
Last update
Sep 7, 2017

Study contacts

Merete Haedersdal, MD, PhD
principal investigator · Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion